A Study Of BMS-986340 As Monotherapy And In Combination With Nivolumab Or Docetaxel In Participants With Advanced Solid Tumors

Study Overview

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

N/A

Cervical Cancer
Gastric/Gastroesophageal Junction Adenocarcinoma
Microsatellite Stable Colorectal Cancer
Non-Small-Cell Lung Cancer
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Renal Cell
Urothelial Carcinoma
Pancreatic Adenocarcinoma
Melanoma
Ovarian Neoplasms
Triple Negative Breast Neoplasms

DRUG: BMS-986340
DRUG: BMS-936558-01
DRUG: Docetaxel

CA052-002
2023-503651-10 (REGISTRY Identifier) (REGISTRY: EU Trial Number)
U1111-1265-4508 (REGISTRY Identifier) (REGISTRY: WHO)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-05-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-03
First Submitted that Met QC Criteria 2021-05-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-06
First Posted (ACTUAL) 2021-05-20	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part 1A: BMS-986340 Dose Escalation	DRUG: BMS-986340 Specified dose on specified days
EXPERIMENTAL: Part 2A: BMS-986340 Dose Expansion	DRUG: BMS-986340 Specified dose on specified days
EXPERIMENTAL: Part 1B: BMS-986340 + Nivolumab Dose Escalation	DRUG: BMS-986340 Specified dose on specified days DRUG: BMS-936558-01 Specified dose on specified days
EXPERIMENTAL: Part 2B: BMS-986340 + Nivolumab Dose Expansion	DRUG: BMS-986340 Specified dose on specified days DRUG: BMS-936558-01 Specified dose on specified days
EXPERIMENTAL: Part 1C: BMS-986340 + Docetaxel Dose Escalation	DRUG: BMS-986340 Specified dose on specified days DRUG: Docetaxel Specified dose on specified days

Primary Outcome Measures	Measure Description	Time Frame
Incidence of adverse events (AEs)		Up to 120 weeks
Incidence of serious adverse events (SAEs)		Up to 120 weeks
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria		Up to 120 weeks
Incidence of AEs leading to discontinuation		Up to 120 weeks
Incidence of AEs leading to death		Up to 120 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)		Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)		Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))		Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)		Up to 120 weeks
PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)		Up to 120 weeks
PK parameters of BMS-986340 administered in combination with docetaxel: Cmax		Up to 120 weeks
PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)		Up to 120 weeks
PK parameters of BMS-986340 administered in combination with docetaxel: Tmax		Up to 120 weeks
PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))		Up to 120 weeks
PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU)		Up to 120 weeks
PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)		Up to 120 weeks
PK parameters of BMS-986340 administered in combination with docetaxel: Ctau		Up to 120 weeks
Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy		Up to 120 weeks
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab		Up to 120 weeks
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel		Up to 120 weeks
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator		At 6 months, 12 months
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator		At 6 months, 12 months
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator		At 6 months, 12 months
Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator		At 6 months, 12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: BMS Study Connect Contact Center www.BMSStudyConnect.com

Phone Number: 855-907-3286

Email: Clinical.Trials@bms.com

Study Contact Backup

Name: First line of the email MUST contain NCT # and Site #.

Phone Number:

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Radiographically documented progressive disease on or after the most recent therapy
Received standard-of-care therapies, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant

Women who are pregnant or breastfeeding
Primary central nervous system (CNS) malignancy
Untreated CNS metastases
Leptomeningeal metastases
Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
Active, known, or suspected autoimmune disease
Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
Prior organ or tissue allograft
Uncontrolled or significant cardiovascular disease
Major surgery within 4 weeks of study drug administration
History of or with active interstitial lung disease or pulmonary fibrosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record